BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREERIDER

    MDR report key: 8276735 · Received January 24, 2019

    Report

    Report Number
    3003820676-2019-00001
    Event Type
    Injury
    Date Received
    January 24, 2019
    Date of Event
    May 10, 2018
    Report Date
    June 12, 2018
    Manufacturer
    FREERIDER CORP.
    Product Code
    INI
    PMA / PMN Number
    K110165
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    WE HAVE RECEIVED UPDATED INFORMATION FROM OUR UK DISTRIBUTOR, THEIR INSURANCE COMPANY THAT THE CLAIM FROM MRS. (B)(6) HAS BEEN DENIED.

    Description of Event or Problem · 0

    (B)(6) 2018 MRS. (B)(6) WAS DRIVING THE SCOOTER UP A SLOPE, AND THEN SHE DROP DOWN CURB. IT CAUSED HER RIGHT ARM, WRIST, THUMB AND HAND INJURED. (B)(6) 2018 MRS. (B)(6) CLAIMED TO UK DISTRIBUTOR ABOUT THIS ACCIDENT EVENT, AND THOUGHT THE SCOOTER IS FAULTY BECAUSE SHE HAD FALLEN OFF TWICE. ONCE COMING UP A CURB AND ONCE PUSHING IT UP THE DRIVE. 01/22/2019 MANUFACTURER RECEIVED THIS REPORT ON JAN./22/2019.

    Description of Event or Problem · 1

    ON (B)(6) 2018: MRS. (B)(6) WAS DRIVING THE SCOOTER UP A SLOPE, AND THEN SHE DROP DOWN CURB. IT CAUSED HER RIGHT ARM, WRIST, THUMB AND HAND INJURED. ON (B)(6) 2018: MRS. (B)(6) CLAIMED TO (B)(4) DISTRIBUTOR ABOUT THIS ACCIDENT EVENT, AND THOUGHT THE SCOOTER IS FAULTY BECAUSE SHE HAD FALLEN OFF TWICE. ONCE COMING UP A CURB AND ONCE PUSHING IT UP THE DRIVE. ON 01/22/2019: MANUFACTURER RECEIVED THIS REPORT ON JAN./22/2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66710 FREERIDER LUGGIE SUPER INI FREERIDER CORP. LUG5ABLJBBAAA1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other